How Colors are Regulated

Regulation of Colors in the US

The US FDA has established regulations for color additives in Title 21 of the CFR, parts 70-82. These color additive regulations identify each listed color additive, provide chemical specifications and identify uses and restrictions, labeling requirements and the requirement for certification. The regulations in 21 CFR part 71 describe the premarket approval process for new color additives or new uses for listed color additives. Color manufacturers routinely carry out quality assurance testing on the products they sell to ensure that they meet the specifications laid out in the Code of Federal Regulations.

There are two categories of FDA approved colors: certified (FD&C) colors and exempt from certification colors. FDA does not consider any color additive to be “natural” and food ingredients such as strawberries and chocolate that contribute their own natural colors are not color additives.

Certified Colors (FD&C Colors)

Color additives subject to batch certification (21 CFR 74) are synthetic organic dyes, lakes, or pigments. A sample of each batch of a certified color is submitted to the FDA for testing to ensure that the color meets the standards set by the FDA.

Exempt Colors

Color additives exempt from certification (21 CFR 73) generally include those derived from plant or mineral sources. Exempt colors must comply with the identity and purity specifications and use limitations described in their listing regulation. Exempt from certification colors do not require additional batch by batch testing but have also been thoroughly evaluated by the FDA.

New Color Approval

Under the current US regulatory system, FDA is responsible for ensuring the safety of new food additives, including new color additive approval.

There is no “generally recognized as safe” exemption to the definition of a color additive. To market a new color additive or new use of an existing color additive, a manufacturer must first petition FDA for its approval. The petition must provide convincing evidence that the proposed color additive performs as it is intended via submission of a battery of studies to demonstrate that the substance would not cause harmful effects at expected levels of human consumption. In deciding whether a color additive should be approved, the agency considers the composition and properties of the substance, the amount likely to be consumed, its probable long-term effects and various safety factors. If the color additive is approved, FDA issues regulations that may include the types of foods in which it can be used, the maximum amounts to be used and how it should be identified on food labels. Federal officials then carefully monitor the extent of Americans’ consumption of the new color additive and results of any new research on its safety.

US requirements for color additive petitions have created substantial safety data for many colors. This data has also been reviewed by WHO/FAO Joint Expert Committee on Food Additives (JECFA) to establish acceptable daily intakes (ADIs). These studies confirm the safety of FDA approved colors, and as a result various color additive have been approved for use in food, beverage, and other products in the US, EU and elsewhere.

Labeling of Colors

US Labeling

All color additives, whether certified or exempt, are considered artificial for labeling purposes in the United States, and the addition of color to a product must be identified on the label (e.g., “artificial color,” “color added”). Use of the term “natural color” is not permitted, as the FDA has not defined the term “natural.” The agency has long considered it to mean that nothing artificial or synthetic, including colors regardless of source, has been included in or added to a product that would not normally be expected to be present.

EU Labeling

In Europe, all food additives are given labeling codes commonly referred to as “E-numbers,” e.g., Allura Red is labeled as E129. Since 2010, the EU has also required a warning label for the Southampton colors, saying that they may have effects on activity and attention in children.

While the EU has required a warning label for the colors included in the McCann et al. study, this requirement was not based on adequate scientific evidence nor on the opinion of the European Food Safety Authority (EFSA), but instead on a political decision taken by members of the European Parliament who chose to forsake the EFSA opinion of the safety of the colors and respond to the emotionally charged public. Consumers, including children, are not in any way at risk from the presence of color additives in foods and therefore a warning label is completely unnecessary and will instead likely confuse consumers by indicating cause for concern where none exists.

Global Harmonization

The harmonization of food additive regulations has become a priority for many nations interested in the global commerce of foods, beverages and food additives. A dominant trend in the global regulation of food constituents is the development of open, positive lists of substances that may be safely added to foods. This trend is consistent with premarketing approval controls that have been the foundation of food additive regulation in the United States since the passage of the 1958 Food Additives Amendments to the Federal Food, Drug, and Cosmetic Act.

IACM advocates for global harmonization of standards and regulations.

IACM supports collaboration and cooperation in building regulatory coherence and international harmonization to facilitate trade and to increase consumer confidence in global food supply

IACM encourages adoption of Codex standards when countries are developing new food regulations. However, some colors approved for use in US not currently in General Standard for Food Additives (GSFA) due to the slow, deliberate Codex process, not due to safety concerns.

The Importance of JECFA and Codex

The future of the global regulation of food color additives largely rests with the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the closely related activities of the Codex Alimentarius Commission.

As its name implies, JECFA is comprised of experts in safety assessment from a variety of scientific disciplines including toxicology, pathology, statistics, and food science. JECFA members are drawn from countries that participate in FAO and WHO activities and include government employees of national regulatory agencies and experts from academia. Membership in JECFA changes from year to year.

Since 1956, JECFA has used its published criteria to conduct safety assessments of food additives, including color additives. Because of its evaluations, JECFA has recommended limits on the acceptable daily intake of food constituents such as color additives. These decisions are published regularly by JECFA. Although JECFA is an independent FAO/WHO Expert Committee and is not part of the Codex Alimentarius Commission, it serves as the scientific advisory body to the Codex on safety issues related to color additives, flavors, and other food additives. JECFA recommendations are also available for adoption by individual countries for inclusion in regulatory programs.